ALKA SELTZER PLUS 2'S BLISTER PACK

ALKA SELTZER PLUS 2S BLISTER PACK by

Drug Labeling and Warnings

ALKA SELTZER PLUS 2S BLISTER PACK by is a Otc medication manufactured, distributed, or labeled by JC World Bell Wholesale Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALKA SELTZER PLUS 2S BLISTER PACK- aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent 
JC World Bell Wholesale Co., Inc.

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ALKA SELTZER PLUS 2'S BLISTER PACK

Drug Facts

Active ingredients (in each tablet)

Aspirin 325 mg (NSAID)*

Chlorpheniramine maleate 2 mg

Phenylephrine bitartrate 7.8 mg

 *nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer 

Antihistamine

Nasal decongestant

Uses

  • temporarily relieves these symptoms due to a cold:
  • minor aches and pains
  • headache
  • runny nose
  • nasal and sinus congestion
  • sneezing
  • sore throat
  • temporarily reduces fever                                                                                                                                                                    

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptom could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • hives 
  • facial swelling 
  • asthma (wheezing) 
  • shock

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older 
  • have had tomach ulcers or bleeding problems 
  • take a blood thinning (anticoagulant) or steroid drug 
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) 
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use to sedate children.

Do not use

  • if you are allergic to apirin or any other pain reliever/fever reducer
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for epression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any its ingredients
  • in children under 12 years of age

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have 
  • asthma
  • diabetes
  • thyroid disease
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for
  • gout
  • diabetes
  • arthrities
  • taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or last more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs
  • nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding,

ask a health professional before use.

It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 

Keep out of reach of children.

In cae of overdose, get medical help or contact a Poion Control Center right away.

Directions

  • adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

Other information

  • each tablet contains: sodium 476 mg
  • Phenylketonurics: Contains Phenylalanine 8.4 mg Per Tablet
  • store at room temperature. Avoid excessive heat.

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, flavor, mannitol, povidone, odium benzoate, sodium bicarbonate

Questions or comments?

1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

Package Labeling:

Bottle3Bottle4

ALKA SELTZER PLUS 2S BLISTER PACK 
aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50269-152(NDC: 0280-1400)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorImprint Code ALKA;SELTZER;PLUS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50269-152-006 in 1 BOX10/30/201903/20/2024
12 in 1 BLISTER PACK
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01310/30/201903/20/2024
Labeler - JC World Bell Wholesale Co., Inc. (805257581)
Establishment
NameAddressID/FEIBusiness Operations
JC World Bell Wholesale Co., Inc.805257581repack(50269-152)

Revised: 10/2023